Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients
First FDA warning letter for nonpayment of GDUFA fee issued against German manufacturer
11:20 AM MDT | October 8, 2013 | Deepti Ramesh
US FDA has issued a warning letter to C.P.M. ContractPharma (Feldkirchen-Westerham, Germany), a contract manufacturing firm, for failing to self-identify and pay its annual fee as required under FDA’s Generic Drug User Fee Amendments of 2012 (GDUFA). The facility has been placed on a publicly available arrears list, FDA says. “Failure to correct these violations promptly may result in regulatory action, including seizure or injunction without further notice; and the facility may also be placed on import alert such that any drug the facility...
This information is only available to Chemical Week subscribers.
Forgot your user ID or password?
Not an IHS Chemical Week member yet?
Here's why you should be:
100% Satisfaction Guarantee